Trial on Education And Clinical Outcomes for Home PD Patients (TEACH)
- Conditions
- Risk Reduction
- Interventions
- Behavioral: Intensive training group
- Registration Number
- NCT01204619
- Lead Sponsor
- Kook-Hwan Oh
- Brief Summary
Since the emergence of home peritoneal dialysis as an alternative to in-center hemodialysis for chronic renal replacement therapy in the late 1970s, the percentage of dialysis patients on PD has continued to decrease each year. There have been a growing concern and research on patient and technique survival of peritoneal dialysis versus hemodialysis to find influential factors for better clinical outcomes. Meanwhile, technique failure rates were significantly higher in small centers treating less than twenty five PD patients. And there was a result for better technique survival after the second year, among the patients trained at the BREC(Baxter Renal Education Center). Better technique survival in large centers can be assumed with not only their more experience with patient management but also their educational infrastructure compared to small-sized centers.
Throughout our experiences in the last 30 years, we have recognized that a major element of PD program is patient training, however few data are available in terms of the relationship between PD training and treatment outcome and mostly are retrospective and non-randomized. Moreover, the technique survival and patient survival were analyzed with no significant difference.
From the insight, we decided to study prospectively to evaluate the efficacy of well-structured education program in terms of various patient outcomes in incident patients on PD.
- Detailed Description
This study will be conducted as multi-center, open-label, randomized, controlled trial. One hundred four patient starting PD will be randomized into two training groups. Patients in the conventional training group (CG) will be given non-standardized in-center conventional training programs plus two sessions of training by home visit, while those in intensive training group (IG) given in-center conventional training programs plus repeated home visits regularly over 24-month period (total thirteen visits). The primary end point of the study is exit site infection (ESI). Secondary endpoints are peritonitis and all-cause infection. Generalized Estimating Equations will be used to assess the adjusted effect of training level on the ESI and Cox regression model employed to evaluate the effect on the peritonitis and other secondary outcomes.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 104
- Incident patients who have PD catheter insertion for starting PD with Baxter solutions
- > 20 yr of age
- Patients who have undergone dialysis or received kidney transplant (note, however, that patients who are currently undergoing emergency hemodialysis temporarily right before the PD do not fall under the exclusion criteria.)
- Patients who are likely to receive kidney transplant or shift to hemodialysis within the following 1 year
- Patients diagnosed with acute inflammatory disease for the past three months
- Patients currently diagnosed with chronic inflammatory disease
- Currently pregnant or breastfeeding
- Patients who are involved in other clinical trial within 30 days prior to enrollment
- Patients who are currently hospitalized in care facilities such as nursing home, etc., or those who are expected to be hospitalized for the duration of the clinical test
- Patients who cannot perform PD by themselves
- Patients considered by the person in charge of the clinical test to have difficulty in participating in this clinical test
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intensive training group Intensive training group in-center conventional training programs + an extra structured patient home visits repeatedly and regularly
- Primary Outcome Measures
Name Time Method Exit site infection 24 months
- Secondary Outcome Measures
Name Time Method Total hours of education and training 24 months Number of ESIs per patient-month 24 months time to the first peritonitis 24 months Systolic pressure and diastolic pressure measured at every visit 24 months Residual renal function 24 months Fluid balance score 24 months Days of hospitalization per year 24 months Average number of antihypertensive medications 24 months Intact PTH level 24 months Total medical cost 24 months Unplanned home visit and education by peritoneal dialysis nurse 24 months K level 24 months Technical survival rate 24 months Patient survival rate 24 months Compliance score of patients 24 months HbA1c only for patients with diabetes 24 months QOL 24 months Kt/V 24 months Hemoglobin level 24 months nPNA 24 months SGA 24 months Total number of hospitalizations by cause over the last 1 and/or 2 years after the dialysis 24 months peritonitis rate 24 months
Related Research Topics
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Trial Locations
- Locations (6)
Wonkwang University, Sanbon Medical Center
🇰🇷Gunpo, Gyeonggi-do, Korea, Republic of
Hallym University Sacred Hospital Puyngchon
🇰🇷Anyang, Korea, Republic of
Gachon University Gil Hospital
🇰🇷Incheon, Korea, Republic of
Hallym University Sacred Hospital Gangdong
🇰🇷Seoul, Korea, Republic of
Eulji Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of